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Tofacitinib citrate, a potential ‘miracle cure’ for hair loss from Alopecia Universalis, has hit the headlines in recent days after the product regrew the hair of a man with this severe condition which causes total baldness. What we have been surprised to see here at The Belgravia Centre is the fact that none of the tabloids have reported on the risk of serious side effects that come with the use of this medication. These side effects include serious infections, tuberculosis and cancer. We examine the condition, this latest treatment and the studies surrounding the controversial drug.

Alopecia Universalis

There are three main forms of Alopecia withAlopecia Universalis being the rarest and the most severe kind. Caused by a genetic mutation of the chromosomes, this type of Alopecia is believed to be an autoimmune disorder. The condition can occur at any age and causes a total loss of hair on the scalp and body – including eyelashes and eyebrows – and can also damage nails. Whilst the hair does spontaneously grow back for some sufferers, even years after the onset of the condition, it cannot be predicted if or when this regrowth will occur.

There is currently no cure for Alopecia Universalis although a range of treatments have been explored, the most recent being the rheumatoid arthritis drug, Tofacitinib Citrate.

Tofacitinib Citrate (brand name, Xeljanz)

Made by Pfizer using the brand name Xeljanz, tofacitinib citrate is a Janus-associated kinase (JAK) inhibitor which works inside cells to disrupt intracellular activities inside the JAK pathways. These are paths within our cells that are used by some signalling proteins (cytokines) to help control immune and inflammatory responses. It is a small, film-coated pill which is taken orally.

Tofacitinib citrate was approved by the FDA for the treatment of moderate to severe cases of the autoimmune disease, rheumatoid arthritis, in adults in November 2012 but was dogged by complaints – firstly about the cost, then about the side effects.

Xeljanz is currently FDA-approved for the treatment of rheumatoid arthritis in the USA and has also received similar approvals for use in Argentina, Columbia, Kuwait, the United Arab Emirates, Russia and Switzerland. Japan have also approved tofacitinib citrate for this type of treatment in adults, however, there it goes by the brand name Jaquinus.

The drug – which is unavailable in the UK as it has not been granted a license by the Medicines and Healthcare products Regulatory Agency (MHRA) – had previously been used to successfully treat psoriasis in humans and to reverse lesser forms of alopecia in mice.

Results of the Yale University of Medicine Study Using Tofacitinib Citrate to Treat Alopecia Universalis

Scientists at America’s elite Yale University School of Medicine used the drug to treat a 25 year old patient who was referred to them for treatment of plaque psoriasis, a chronic immune-mediated skin disease, and the most common strain of psoriasis, which displays as inflamed, scaly skin.

However, his diagnosis of Alopecia Universalis – which had never been treated – was also noted by the medical team and they decided upon the tofacitinib citrate treatment in order to try to cure both conditions.

The unnamed patient was almost completely hairless when he started the treatment, with the only hair being within the psoriasis plaques on his scalp.

After taking an 8 month course of tofacitinib citrate which involved 10mg per day for two months, followed by 15mg of the drug per day for another three months, the treatment was deemed to be ‘mildly effective’ in treating the patient’s psoriasis, however, he saw amazing results in terms of hair regrowth.

The subject had completely regrown scalp hair, developed eyebrows, eyelashes and facial hair, armpit hair and other hair – the first hair the man had grown in seven years.

This Yale study is the first reported case of a successful, targeted treatment for the rare Alopecia Universalis condition.

The paper detailing the Yale study, “Killing Two Birds with One Stone: Oral Tofacitinib Reverses Alopecia Universalis in a Patient with Plaque Psoriasis” (ref: J Invest Dermatol. 2014 Dec;134(12):2988-2990. doi: 10.1038/jid.2014.260) was written by Brett A. King, M.D., assistant professor of dermatology at Yale University School of Medicine and his dermatologist colleague, Brittany G. Craiglow, M.D.

Dr. King explained, “The results are exactly what we hoped for. This is a huge step forward in the treatment of patients with this condition. While it’s one case, we anticipated the successful treatment of this man based on our current understanding of the disease and the drug. We believe the same results will be duplicated in other patients, and we plan to try.”

He concluded, “There are no good options for long-term treatment of alopecia universalis. The best available science suggested this might work, and it has.”

Clinical Trials & the Reported Side Effects of Xeljanz

The study’s co-author, Dr. Craiglow, said, “By eight months there was full regrowth of hair. The patient has reported feeling no side effects, and we’ve seen no lab test abnormalities, either.”

The results from this study are extremely encouraging, however, further, wider-scale clinical trials are required in order to establish whether the use of tofacitinib citrate in combating Alopecia Universalis, as well as potentially other forms of hair loss, is safe. Particularly given the alarming side effects associated with the drug in connection with its treatment of rheumatoid arthritis in adults and various other conditions it has been tested for as a potential remedy, including Crohn’s disease, dry eyes, plaque psoriasis, renal transplant rejection,ulcerative colitis, and ankylosing spondylitis.

Many clinical trials of Xeljanz have been, and continue to be carried out in relation to the drug’s suitability and safety as a treatment for rheumatoid arthritis and psoriasis. Yale’s Dr. King has already submitted a proposal for a clinical trial involving a cream form of tofacitinib as a treatment for alopecia areata.

Phase III clinical trials for the study into the Long-Term Effectiveness And Safety Of Tofacitinib For The Treatment Of Rheumatoid Arthritis are still under way, with results expected in 2019. However, the Phase II trials tested Xeljanz in Rheumatoid Arthritis patients that had not responded to other therapy and found the most important side effects to be increased blood cholesterol levels (12 to 25 mg/dl LDL and 8 to 10 mg/dl HDL at medium dosage levels) and neutropenia, a granulocyte disorder whose key symptom is a deficit of white blood cells which can then lead to an increased risk of infection.

Currently scheduled until November 2019, on-going clinical trials for the drug started in February 2007. In April 2011, four patients died after beginning clinical trials with tofacitinib citrate; Pfizer said that only one of the four deaths was related to tofacitinib.

In April 2013, Arthritis Research UK reported that the European Medicines Agency (the regulatory body in charge of drug approvals in the EU) had been advised not to approve tofacitinib for treatment of rheumatoid arthritis, saying ‘The European Medicines Agency (EMA) is unlikely to approve a new medication called tofacitinib citrate (brand name Xeljanz) for the treatment of adults with rheumatoid arthritis, after its Committee for Medicinal Products for Human Use (CHMP) failed to produce a positive recommendation… The committee also had “major concerns” about the medication’s safety with regard to serious infections, certain cancers, gastrointestinal perforations, liver damage and blood fat levels… Therefore, at that point in time, the CHMP was of the opinion that the benefits of Xeljanz did not outweigh its risks and recommended that it be refused marketing authorisation’.

Funmi Lampejo, Pharmacy Manager at The Belgravia Centre’s City of London clinic, explains, “Tofacitinib is an immunosuppresant. It works by damping down the immune system so that the progress and symptoms of diseases caused by the body’s own immune system attacking it can be slowed and relieved. The problem with that is that the body is not protected from opportunistic infections, and cancers are more likely to develop in the long term.”

“Essentially, they decided that the drug tofacitinib did not offer any added advantage over existing immunosuppressants, and had a worse adverse effect profile compared to drugs already on the market, particularly in patients with resistant rheumatoid arthritis. In addition, they were concerned about the incidences of serious side-effects such as cancers, infections and digestive tract problems. As the dose which may be effective for alopecia totalis and universalis has not yet been fully established, it may turn out that the adverse effect profile may improve. It is too early to speculate either way.”

The EMA’s Assessment report on Xeljanzfrom July 2013 highlighted a number of the European regulatory body’s ‘major concerns’ about the drug’s serious side effects and the Benefit-Risk balance.

Although the most common side effects of Xeljanz in its usual role as rheumatoid arthritis medication, were found to be upper respiratory tract infections, headaches, hypertension, diarrhoea and inflammation of the nasal passage (nasopharyngitis), the current Safety & Side Effects warnings on the product’s website and packaging clearly state that ‘Xeljanz may cause serious side effects’. These include:

Serious infections: ‘Some people have serious infections while taking Xeljanz , including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.’

Cancer and Immune System Problems: ‘Xeljanz may increase your risk of certain cancers by changing the way your immune system works.’

Tears (perforation) in the Stomach or Intestines: ‘Some people taking Xeljanz get tears in their stomach or intestine. This happens most often in people who also take non-steroidal, anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.’

The manufacturers also state that Xeljanz is not suitable for those with infections, liver, kidney or stomach problems including ulcers, and it should not by used by women who are, or are planning to become, pregnant. There are various other conditions where the drug is deemed unsuitable, such as if the patient has recently been vaccinated.

Alternative Treatments for Alopecia Universalis

Until the Tofacitinib Citrate study outlined above, the most effective treatment for Alopecia Universalis was thought to be topical Immunotherapy. This shocks the hair follicles into production by creating an allergic reaction on the affected areas of the skin. The treatment has a success rate of around 40% and needs to be ongoing for hair growth to continue, but reported side effects – most commonly including persistent dermatitis, generalized eczema and blistering – can be unpleasant.